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Federal Report: Theranos Blood-Testing Devices Often Failed Accuracy Requirements

CMS considers sanctions

The blood-testing devices that Theranos Inc. has touted as revolutionary often failed to meet the company’s own accuracy requirements for a range of tests, including one to help detect cancer, according to an article in the Wall Street Journal. The Journal got an early look at a federal report detailing deficiencies found by the Centers for Medicare and Medicaid Services (CMS) during its inspection of Theranos’ Newark, California, laboratory last fall.

The report offers the first outside glimpse at the performance records Theranos compiled for its proprietary blood-testing devices, code-named Edison. Federal inspectors found that 29% of the quality-control checks performed on the devices in October 2014 produced results outside the range considered acceptable by Theranos. Moreover, in February 2015, an Edison-run test to measure a hormone that affects testosterone levels failed 87% of quality-control checks, the report said.

The federal inspectors also cited the Theranos lab for performing tests with unqualified personnel, for long delays in notifying patients of flawed test results, and for storing blood samples at the wrong temperatures.

In October 2014, an Edison-run test to measure the hormone prolactin failed 47% of quality-control checks, the report found. In April and May 2015, a test to measure prostate-specific antigen (PSA) failed quality-control checks 22% of the time. The PSA test is used to help detect prostate cancer.

Federal inspectors also said the Edison devices produced test results that differed widely from those of traditional lab machines for the same blood samples. For example, when measuring vitamin D, the gap between Edison devices and traditional machines ranged from 21% to 130%, based on the inspectors’ review of nine samples randomly selected from an internal Theranos study.

Theranos did not respond to specific questions from the Journal about the performance of its Edison machines, as detailed in the inspection report.

The CMS plans to impose sanctions against Theranos, according to Journal sources. In January, the agency said the punishment could range from fines to suspending or revoking the laboratory’s certification to legally test human samples.

Source: Wall Street Journal; March 31, 2016.

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